This invention relates to providing a medical component system assisting more efficient and safer performance of medical procedures. More particularly, this invention concerns a multicomponent medical system comprising apparatus and methods for improved resuscitation, suction, aspiration, irrigation, lavage, monitoring, intubation, sampling, visualization and improved organization of medical devices. Typically, in the field of medicine, it is frequently necessary to use a combination of devices together to perform a single procedure or a series of related procedures. It is possible that these separate devices or components may have other similar functions for other related procedures or may have independent functions unrelated to a first procedure. These components may also be optional within the first procedure or interchangeable with other similar components. With such medical components and co-use problems, especially where suction devices are in use, there are also existing problems in areas like: sterileness; location and retrievability; intubation and resuscitation (especially with meconium problems with newborns); regulation and efficiency of suction devices (including meconium aspirators) and endotracheal adapters/tubes; specimen collection; splash shielding; syringes; monitoring; visualization and illumination; irrigation; etc.
With respect to sterileness, for example, suction and vacuum devices are commonly used to remove substances from a body surface or cavity. Because of the nature of use, these devices are often required to be sterile or as hygienically clean as possible. Many millions of dollars are spent each year in the United States to make sure that inexpensive plastic products are sterilized according to strict standards and remain sterile during transport and storage. This is generally to assure that infection is not spread from a medical device to a patient who is at higher risk of susceptibility, such as having an open wound or during a surgical procedure where internal portions of the body are unusually exposed to the external environment. Once a device is removed from its storage container, it often must remain sterile, or at least a portion such as a tip of the device must remain sterile. With great effort and expense, users of the device must maintain this sterility or hygienic standard. For example, clinicians often wear sterile gloves not only to protect themselves from infection but to maintain the sterility of the equipment they are using and placing into more sensitive regions.
For example, a vacuum tube or hose often connects from a nonsterile region (such as a wall regulator) to a sterile region (such as a surgical field). This tubing is often six to twelve feet in length and ⅜″ to ½″ in diameter; and a proximal end is often connected to a vacuum source or to a wall regulator and the distal end is placed in a field of use. Because the floor is not a hygienic surface, these devices are often placed on tables or trays above the ground, for safety and easy access. Because the weight of the remaining tubing is often substantial, particularly in relation to its end portion, the distal end is often pulled by the force of gravity or the elastic force of the tubing off a flat surface, interfering with its sterileness.
A similar problem is encountered in the organization of medical devices, not only in relation to the purpose of sterility but for the improved preparedness of a medical device. By having devices in easily recognizable and therefore retrievable locations, the efficiency of a medical procedure can be enhanced. Because of the weight of the vacuum tubing used in the above example, the devices often slide or move from desirable locations to undesirable ones in an often unpredictable way. Even if the device remains in a sterile field it may be in a place that is unanticipated or difficult to access. Often the procedure has no sterility requirements but requires speed and efficiency such as in a portion of the resuscitation of a critically ill patient. In such a case, where many things are occurring in a short time span and the consequences of success or failure are truly life or death matters, it is of utmost importance to maintain as much order as possible for efficiency and success. Often one uses a single device and then must put it down to tend to another task. Then it may be desirable to reuse the same first device. If the first device must remain sterile, then putting it down may contaminate the device and/or the device it is connected to.
Numerous devices or techniques are used to maintain medical devices, and specifically vacuum devices such as a vacuum hose or a suction catheter, in a sterile or desirable location. One technique is to avoid putting down the suction tube and continuously hold it until its use is completed. This technique obviously limits the dexterity remaining of the user's hands, which must constantly hold a device while possibly attending to other tasks. Another technique is to put down the device; and if the device is contaminated or lost, for example, to use a new one. This adds to the amount of equipment used, to the time to locate and prepare the new equipment, and to the total costs of using such excess equipment. Sometimes, a distal end of a tubing is placed in a pocket, such as one formed with the sterile patient draping in an operating room, with the frictional force of a tube hanging over the pocket keeping the device in place. Unfortunately, there are not sterile pockets located in all locations where they would be desirable. In addition, when the distal end is needed, or a device attached to the distal end is needed, the device must be retrieved from the depth of the pocket, and if one is to pull on the exposed tubing, then the device on the distal end of the tubing within the pocket may be pulled off and disconnected from the tubing by the frictional forces of the restraining pocket. Such “fishing out” of the distal end of a vacuum tubing is time-consuming and cumbersome enough without having to additionally retrieve and orient and attach a disconnected medical device within the pocket.
With respect to prior attempts to solve such retrievability and sterileness problems, clamps have been designed that affix to the side of a fixture and provide an open ring or clamp for a hose to fit into. For example, dentists have open rings attached to their assemblies into which a hose can slip. The disadvantages of these gripping devices is that they are in fixed locations. Similar to the pockets described above, they are limited by their location and availability. Their location may be in an awkward location, i.e., that is difficult to access. For example, if a surgeon needs to reach across an open body cavity to reach for an attachment, that is a location difficult to access. Such gripping devices are separate from the medical devices and do not travel with the medical device and the location of stabilizing the medical device is limited by the location of the fixed-location gripping device. As fixed devices, they are more likely to be nondisposable or frequently used or reused. If sterility is required, these fixed devices may be difficult to maintain in an hygienic condition.
In the prior art, for example, devices such as pens and beepers have restraining devices such as clips that allow these devices to be attached to pockets or belts. But these gripping devices may not be of material that is easily sterilizable and, since they were not intended to attach to medical devices, they lack the correct dimensions, for example, to be applied to suction tubing. These clips, even if they could be applied to suction tubing, do not have specialized internal retaining surfaces having the capability of accommodating a variety of tubing sizes of certain medical standards, such as an 8 Fr, and such variety of dimension-accepting capability is important in the medical field. A single vacuum hose, for example, is designed to have the potential to connect to a variety of suction catheters with flexible tubing of a variety of dimension. A ‘clip’ that is appropriate for an 8 Fr diameter tubing, could be very tight for a 14 Fr tubing. It may not accept the larger tubing and would therefore not perform its desired gripping function, or it may grip it in too tightly, causing too great a compression on the tubing; and that may damage its shape and cause a dangerous kinking of the tubing or a constriction or an irregularity making it dangerous to use. For example, if the tube has a sharp kink with a sharp narrowed outer diameter, that might cause a dangerous scratching when inserted into the nasal passages.
Another technique to restrain a suction tube device, for example, might be to put a weighty object on the distal end of the vacuum tubing or on a device attached distally to this vacuum tubing. The problems with such a technique include the possibility that the tubing and or the device may become hidden underneath the weighty object; or the weight of the weighty object may kink or deform a suction tube; or, if the weight is placed over a distally attached device, this device may remain fixed, but the gravitational or elastic forces of the tubing may pull away from this stationary device and cause a disconnection. Additionally, the suction tube may undesirably fall onto the floor, or this disconnection may cause other potentially dangerous situations, as in the example of a resuscitation requiring tools and devices and where procedures must be done as swiftly as possible.
Yet another similar problem may occur when the flexible tubing described above is unrestrained. Under such conditions, the free end may be under limited control due to the elastic and gravitational forces of the tubing that cause it to move when unrestrained. This might cause detrimental effects, even trauma, as by leaving a catheter next to a patient's head. For example, if the catheter were left unrestrained next to an unconscious patient during a resuscitation before the patients eyes were taped closed, it might move and rub over a patient's cornea causing an injurious and painful consequence on an already debilitated patient. So better devices and techniques for device and tubing restraint are needed.
Turning now to prior art problems with intubation and resuscitation, the medical procedure of intubating a patient is frequently necessary to resuscitate a patient who is in distress. This procedure involves many devices which must work together in an efficient manner to save time and to allow the users to concentrate on the condition of their patient and not on the condition of their medical devices. Resuscitation of a newborn with meconium is one subset of those persons that are intubated for a resuscitation procedure. The resuscitation of a newborn child with meconium will be described, as it is a good example of the needs for improvements in these areas.
Meconium is fecal matter that an infant expels in utero. It is one of the thickest, most tenacious and viscous matters of the human body. During the first few seconds of life, a child with meconium in its trachea may need to be intubated by a clinician to remove the meconium to prevent a physical obstruction of this matter in the trachea. This is done to prevent asphyxiation and to prevent the deposition of this matter in the lower respiratory tract of the newborn, which might result in a syndrome similar to a chemical pneumonitis called meconium aspiration syndrome. Such a situation is one of the few instances in which an endotracheal tube is inserted into the trachea of a patient for the purpose of aspiration rather than ventilation, the usual objective of endotracheal intubation. The procedure of aspirating meconium must be done quickly as the longer the procedure takes, the more likely that the newborn patient might develop bradycardia and secondary acidosis leading to a downward-spiraling course in which the patient is more and more difficult to reverse. It is noted that once the umbilical cord is cut the newborn is deprived of its oxygen supply and cannot receive oxygen until the lungs are inflated. This action is usually desirably delayed by lack of stimulation of the newborn until after the many steps of intubation and aspiration are accomplished by the resuscitation team. It is therefore of the utmost importance that all steps are taken to reduce the time for the procedure and to increase the likelihood of a swift and successful procedure while also minimizing the risks to the patient that such an important procedure can cause. Improved preparation and improved organization of the devices prior to, during and after the procedure are all means by which the risks to the patient can be controlled—risks that are independent of the technical skills of the clinician. After the resuscitation phase, if the resuscitation is successful, the newborn patient must be stabilized and certain routine, although necessary, steps must be taken. For example, a critical patient may need to be reintubated for the purpose of ventilation, or ventilated with a resuscitation bag and mask; and other clinical assessments of the patient may be taken at that time, such as assessment of muscle tone or pupillary function. Most of these procedural elements are not unique to newborn patients, and can be generalized to use in adult patients. Although due to many differences in size and physiology, these procedures in newborns and pediatrics require special dimensions or techniques that may be unique.
With respect to regulation and efficiency of suction devices (including meconium aspirators) and endotracheal adapters/tubes, there are many problems not solved and often not even addressed by the prior art. It is common in the field of medicine to use suction devices to remove gases, liquids, semi-solids and solid material from a cavity or surface of a body. These devices often have a valve that allows regulating the suction force applied at the opening at the patient end of the device. Most suction sources, such as wall units or portable ambulance units of vacuum are now regulated to be at a constant force using a machine source and a vacuum regulator. The regulator determines the level of suction at the source of suction. Usually it is desired to have an ability to regulate this constant source, since, for example, it is difficult and undesirable to suction while advancing within a body cavity. One usually suctions while withdrawing. In order to control the vacuum at the distal patient end of the device, suction control valves have been developed to regulate this flow at a point closer to the patient than the source regulating unit. Suction devices require much dexterity to operate in the field of medicine and therefore they are generally hand-held units that attach to flexible vacuum hosing. Sometimes the hand-held suction devices are of disposable plastic, but they may also be of metal. In the United States, this material is preferably an FDA class VI material and other countries will have their own similar material specifications for biocompatibility of plastics and other materials. Frequently the distal suction regulatory valve for such unit is on the wand of the hand-held suction device. Such device in its simple form is a single tube interrupted by a suction regulation means. In intubation, it is necessary to suction a patient's oropharynx to clear the area above the vocal cords, so that the vocal cords can be visualized; thus one can properly intubate a patient using the vocal cords as a visible landmark.
With respect to meconium aspirators, these devices are not always used, as only 10% of newborns have meconium and of these, not all are intubated. So meconium aspirators are not always in use. Sometimes, depending on the design of the device used, they are interchanged with a suction catheter coming off of the same hose. When not in use, these devices can often get lost under the warming blanket of a baby or be pulled off a warming table, by the weight or elastic force of a vacuum hose, onto the floor. If this occurs, the procedure would be delayed and equipment may need to be replaced. Since any procedure in which a meconium aspirator is used involves a patient that is being resuscitated, any delay can be extremely detrimental to the success of the procedure and possibly to the patient. Prior art does not describe any restraining means for preventing this spatial displacement of meconium aspirators. In addition, because meconium aspirators are not used in 90% of deliveries, they are often not stocked adequately by hospital personnel. The prior art does not describe a flexible suction catheter restraint on a meconium aspirator for a simple tubular meconium aspirator with an end inlet and end outlet.
It is often desirable in designing medical devices to keep the design as simple as possible for a variety of reasons. This principle would apply to any flexible suction catheter restraints, including those on meconium aspirators. For example, because oddly placed appendages are additional projecting points, they can be points that can be potentially traumatic to a newborn if accidentally scratching a body surface. In addition, such appendages can be sharp enough to burst through a sterile package and compromise the sterility of the package.
The prior art describes a one-handed method of using a meconium aspirator with an end inlet and end outlet and a side control port, but this prior described method of using a meconium aspirator requires the operator to put the hand in an awkward position since the device is vertically attached to the endotracheal tube. The vertical positioning of the hand is awkward. Also, the side port is not in a predictable position. Since the elastic forces of the vacuum tubing that the meconium aspirator is attached to may cause the device to rotate as the generally vertical connection is made, the side port may be in any position around the generally vertical connecting axis. Even after such awkward generally vertical connection is made, one then must locate the side port. The prior art does not describe a meconium aspirator with a less cumbersome attachment for the operator.
With respect to connecting a meconium aspirator to an endotracheal tube, the prior art describes tube connecting telescopically and frictionally with a male tapered endotracheal tube adapter. While this type of connection has an advantage of providing an easily made connection, it has disadvantages as well. For example, the point where a desirable seal is formed in the connection is unpredictable and can vary greatly with different dimensions of width, height, and angle of the outer wall of the endotracheal tube connectors provided by different manufacturers. While these endotracheal tube connectors generally conform to certain standards, even within this standard range there is the chance for a remarkable amount of variability. There is no teaching of an endotracheal tube connector port, including specifically one to be used for aspiration of the endotracheal tube, or including one to be used for meconium aspiration, that includes a system providing a repeatable point of forming a seal line with the telescopically and frictionally connected endotracheal tube connector. With a tapered design such as that described in the prior art, for a telescopic interfitting, one would not know where along the depth of the sidewall one would make a seal. Since the endotracheal tube connectors are of a small height and the depth of the inlet for the suction must be above a seal line to prevent the leakage of suction forces, this inlet must not be too high so that it is not easily occluded be a finger over the larger suction controlling inlet. It is an object and feature of the present invention to have a fixed diameter at a fixed depth rather than a tapered inner diameter forming a seal line so that one would know that, even using a variety of manufacturers' endotracheal tube connectors of various standard dimensions, one could still make a seal at a specific point on the device and therefore insure that the seal is attainable and is not compromised by a leak from the suction catheter inlet port. There is no teaching in the prior art of an endotracheal tube connector inserting into an endotracheal tube connector port, including specifically one to be used for aspiration of the endotracheal tube, or including one to be used for meconium aspiration, that has an opening in which the control feature occurs by the endotracheal tube connector forming a seal at a point proximal to a distally positioned side inlet for a suction catheter, including a seal formed by a diameter of a fixed dimension.
With respect to the areas of specimen collection and use of gloves, when using a gloved finger over a control port, the elastic glove might get sucked into an inlet port under high vacuum pressure. This is undesirable as it might be difficult to remove and therefore difficult to deactuate a suction unit, which could have dangerous results for a patient. In addition, a glove that extends into a suction inlet control port could occlude another inlet and prevent the inflow of substances. So it would be very useful to have a system for preventing such things.
In addition, as previously described, it is desirable to not only prevent malfunctioning of equipment, but also to prevent user contamination and user initiated cross-contamination. While gloves, such as commonly used latex or vinyl disposable sterile and non-sterile gloves protect a user from direct contamination, they can also be a source of cross-contamination if the gloves get infectious material on them and the user is not meticulous about the surfaces or patients that she later touches. It is therefore preferable to have devices, such as a suction catheter with a finger valve that limits the contamination of the controlling gloved finger, to prevent the dangers of indirect cross-contamination.
In addition, in meconium aspiration procedures, it is often desirable to regulate flow through the system even after the endotracheal tube has been connected. It would be desirable to have a device that could accommodate an endotracheal tube for the purpose of meconium aspiration and have a suction catheter inlet for routine suctioning and have the ability to be regulated easily with a minimal amount of manipulation and preferably involving a single finger.
Also, because meconium aspiration is a procedure which has a limited number of uses, it would be desirable to have a meconium aspiration device that could be useful for other procedures so that the product would have wider market and therefore might allow manufacturing and marketing costs to be reduced. The prior art does not describe a device configured like a meconium aspirator with the following objects and features of the present invention, firstly, for example, that it can also be used with a cap as a suction device with an actuator that reduces splashback on the controlling finger over the control valve. Nor is there described such a suction device with an enclosed specimen trap for sampling of respiratory secretions that might include, as an object and feature thereof, an inner appendage to increase the internal surface area to improve the function of the trap. Nor does prior art describe a device configured like a meconium aspirator that can also be used over a wound for efficient irrigation of the wound, and that might include the other useful features described herein for novel splash shields. Nor does the prior art describe a device for use in meconium aspiration that overcomes the limitations described above and preferably accommodates a user-determined option of using an endotracheal tube with a stylet either for intubation, either separately or in combination with the meconium aspirator device.
With respect to the regulation efficiency of suction valves, there are open and closed suction regulatory systems. In general, an open system will allow atmospheric room air into the system and a closed system will not. In its simplest form, a suction regulatory valve is a hole in the tubing than can be occluded. Occluding the regulatory hole causes a larger force to be applied to another inlet of the system. Different problems have been encountered in the development of open regulatory systems. With a control valve on the side of the device, occluding the device with a finger may cause suctioned debris to splash on the side of the controlling finger. One method of preventing this is to raise the level of the controlling aperture above the level body of the suction device. Such prior open hand-operated open suction control valves vary the pressure by opening and closing the occlusion of the controlling aperture. In general, if the device is unoccluded, air flows in and very minimal suction force is applied at the patient end. In general, if the device is partially or fully occluded, then the device is “on” and suction force is applied partially or fully to the distal end.
Unfortunately, though these designs claim to vary suction, their variable control is limited. These limitations are worsened even more now that personnel universally use gloves when operating these devices which in general reduce sensation and feedback. The useful variation in the prior art is only in the fully on and the fully off function. At the present state of the art, it is very difficult for a user to distinguish by sensing means any intermediate points of occlusion. In the intermediate levels of suction, the designs do not provide any way to repeatably and reliably regulate intermediate levels of suction. Of course one could adjust the regulating unit at the vacuum source, but that unit may be located far away from the user and would be inconvenient to change, since a procedure might have to be interrupted, etc. and such a delay in the midst a resuscitation could have severe consequences.
Actuators of different types have been developed to attach to suction wands to attempt to provide some intermediate control. Some operate by sliding over a hole or twisting with a screw-type actuator to occlude a hole. These devices, however, are more difficult to manufacture than a single piece. They are generally more expensive to produce and require moving parts that may break or malfunction, and they require a manipulation of the operator's hand to position properly on the actuator and adjust the suction to a desired level. And that level must then be confirmed by the operator—often and visually, such as looking at a dial or slide gradient. Similarly, if one would want to change the position, one must again position the hand and fingers into an active position over regulating surfaces and then manipulate the fingers to effect the desired change. While these devices may be more effective than older systems in generating variable forces in incremental or repeatable ways, they have the problems described above. In addition, the step of “deactuating” a suction device may require instantaneous attention which might be slowed by the process of changing the position of the actuator. In addition, actuators might mistakenly be left in an “on” position which might cause traumatic results if the suction wand were applied to a fragile body surface in a careless fashion. In fact, even when carefully controlled, applying a suction using such actuators, particularly a full suction, can cause problems.
This problem of applying a closed vacuum system to a fragile surface has been addressed by few. One problem of significant concern is what happens when the suction device comes against a body surface and the body surface is sucked into the suction device aperture. If there is no regulatory suction control valve or if this control valve is fully activated, then the device becomes a closed vacuum system. As body tissue is generally more fragile than medical equipment, the weakest portion of the system, the body surface, is sucked into the suction device. Removing the device may cause tearing of the body surface, which may fragment critical body parts or blood vessels with resulting organ injury or hemorrhage. It is a standard practice for suction catheters produced now to have “eyes” at their tips. These apertures are generally located with the side wall of the device at the suction catheter or suction tube tip at the patient end. The Poole tip large number of such holes is to prevent this traumatic suctioning from occurring. Others have addressed this problem at the level of the tip, but these devices are not conducive for suctioning in all body areas, nor are they used frequently. Even under optimal conditions, these suction tip devices, including flexible suction catheter tip “eyes”, may become occluded. For example when suctioning a narrow space such as the nasal passages of a newborn, a suction catheter tip may have the side openings against the wall of the nasal cavity, and therefore become ineffective. If the tip opening were to get occluded while a fully ‘on’ suction force were applied, then there would be no safety relief mechanism. While this full force of suction can be dangerous, sometimes it is, however, desired. An analogous situation outside the medical field is that of using a household vacuum cleaner. Sometimes you need a full vacuum force to remove a piece of debris clinging to a rug. However usually you do not want a full complete vacuum force applied because this would suck the rug into the vacuum hose tip and make it difficult to slide and maneuver. It might even pull the rug from its position on the floor and might damage the rug fibers.
There has been described in the art a hand held suction valve with an aperture elevated above the level of the suction body. This device offers the value of having relief mechanism located somewhere other than the device tip and in the body of the hand wand that doesn't require any moving parts. Unfortunately, this device still only provides the on/off repeatable regulation of the prior art and does not teach a variable repeatable incremental regulation. In addition there is no teaching in the prior art to accommodate the need for higher levels of full suction. The vacuum relief mechanism would always be on. Even if one were to modify the device by possibly occluding all ports for the device, it could not be done simply by a single finger or without the use of an actuator. The relief valve can not be instantaneously closed by a single finger that is also controlling the main portion of the regulatory valve on the top of the device. Similarly, the relief groove is at an awkward angle in relation to the main regulatory port and could not be controlled be a single finger by itself and would require an awkward hand manipulation, or an actuator or control by an additional finger.
Another difficulty with the prior art is the lack of a simple hand held medical suction device with a simple fine regulatory mechanism that is instantaneously available without the use of moving parts. Different actuators such as slides, clamps and dials with screw-type actuators have been developed; but for more variable suction control, they have similar disadvantages. Again, while the prior art inventors may describe a device with some variation, they do not show how this regulation can be done in a repeatable incremental way nor with fine control over the final portion of occlusion. If one wanted to do variable suctioning that is intermediate between the on and off positions, it can only be done haphazardly without a fine tuning mechanism, or only by one with extraordinary skill, leaving patients under the care of those with less experience in potential danger. The standard nursing principle of using “the lowest suction possible to achieve the desired result” is not achievable or easily achievable with the current art.
In my prior U.S. Pat. No. 5,562,077, I describe a structure for fitting an endotracheal tube adapter within a suction device and attempting to cover the suction inlet port with the adapter; however, such a system does not make an efficient and identifiable seal line proximally of the inlet port, a requirement for efficient use. So even here, improvement is needed. Additionally, I showed in that patent how to temporarily restrain such an adapter on the suction device body; however, in medical situations, as stated above, many types and sizes of devices should be restrained in handy and efficient positions. Here too, improvement is needed.
Nevertheless, to review, suction devices such as open held suction catheters, particularly hand-held surgical respiratory suction catheter devices including those with flexible tubing, including those with either a T or Y configuration: may not have any means for preventing splashing contamination of a controlling finger; may not have means for variably controlling suction pressure in a position intermediate from fully on or fully off that can be repeatably and incrementally controlled; or may require an intermediary actuator that require assembly from separate parts, are costly, cumbersome, complex, non-instantaneous and have the potential to malfunction and may be left in an undesirable actuated position; may not have a relief mechanism, or if having a relief mechanism, it does not accommodate a complete regulatory occlusion of all non-patient end regulatory ports by a single finger, including the relief mechanism, such as a relief port that is on the suction wand itself; may be unnecessarily prone to trauma; may require an awkward hand manipulation; may not have a relief portion; or may not provide a variable and repeatable incremental suction.
Now, with respect to design of endotracheal tube adapters, endotracheal tubes with endotracheal tube adapters are devices that are intended to be inserted through the oropharynx of a patient to accomplish ventilation and occasionally aspiration of a patient's lungs. The tube portion inserts into the patient's trachea. The adapter portion is outside the patient and connects to respiratory tubing or other connecting devices which usually will be promoting the ventilation of the patient. There is the occurrence of meconium aspiration in which aspiration occurs through the endotracheal tube. Typically, the endotracheal tube adapter has a top diameter which is of a standard diameter with walls tapering within a standard dimension for inserting into a female portion of another connector such as respiratory tubing. The adapter lower portion has a tapered male connector fitting into the proximal portion of an endotracheal tube.
A stylet optionally goes through the entirety of the central portion of an endotracheal adapter and inserts into the endotracheal tube giving it more rigidity and form. This assists in control and placement of the tube during intubation, i.e., the process of inserting the tube into the patient. The stylets are generally longer than the endotracheal tubes. The stylets are also flexible and the extra proximal length of the stylet is usually curved over the upper portion of the endotracheal tube. It is often necessary to secure the stylet further. This can be accomplished by securing the stylet around flanges extending from the lower portion of the outer wall of the endotracheal tube adapter if they are so designed. Such flanges serve other functions. The flanges help with visualization of the endotracheal tube when its outer surface is covered by the female end of a respiratory connector. And the flanges can act as a friction enhancing object for generating a rotational force on the device or causing an upward or downward force relative to the connector depending on whether connection or disassembly is desired.
Typically, in the prior art, the devices which have flanges which are designed to also secure a stylet have two flanges. This presents a problem since it is difficult to generate and control a twisting motion on an endotracheal adapter from above when the device is connected to other respiratory devices, since the other respiratory devices obstruct this manipulation from above. Therefore a twisting motion cannot be easily accomplished, as would be done with a jar lid, and must be accomplished generally from the side. The only possible twisting that can be done is with one flange being pushed outward while the other flange, at 180 degrees to the first, is drawn inwardly. This is a difficult manual manipulation. With respect to flanges and stylets, the flanges serves a protrusion around which the stylets are wound. The elasticity of the material of the stylets frequently causes these stylets to pop off the roughly designed flanges. The stylet might then twist within the endotracheal tube cause the distal end to be reoriented in an undesirable and potentially dangerous configuration. The released and unrestrained stylet might also be at an undesirable depth. If the stylet is too deep, it could easily cause a devastating perforation of trachea or similar harm to a patient as it would protrude beyond the protective tip of the endotracheal tube. If the stylet is too short, it would leave the distal tip of the endotracheal tube without the desired stiffness, defeating the purpose of inserting the stylet. This problem is particularly important in the use of endotracheal tubes for newborns and pediatrics where the dimensions are more critical, where stylets are more likely be necessary to be used, especially by less experienced personnel and where trauma is more likely to occur due to the smaller dimensions and often more fragile body structures. It would therefore be desirable to have a flange of an endotracheal tube that would provide a more specialized retention means for securing a stylet to prevent the limitations of prior art.
Also, because the combination of an endotracheal tube and endotracheal tube adapter is generally accomplished by a telescoping frictional means of a larger diameter device interfitting with a smaller diameter device, this connection is often unstable. The ‘wobbling’ of the wider device on the narrower device can cause the release of this connection and can cause a break in a vital respiratory circuit depriving a dependent patient on sustaining ventilation.
Typically, also, in the prior art, there have been problems with dead space and reduced diameters in endotracheal tubes, especially in working with newborns. In pediatric medicine and particularly in neonatology, the dimensions of the endotracheal tubes fitting into the trachea are more narrow than for adults since the tracheas are much more narrow. The industry maintains a standard outer diameter of the endotracheal tube adapter, but a reduced diameter of the conduit attaching to an endotracheal tube. It is desirable for the inner diameter of the endotracheal tubing to be maximized with the restraints of the outer diameter given that the resistance through the tube is inversely proportional to the length of the tube radius to the 4th power. Therefore small changes in the inner diameter significantly affect the resistance in such systems. Even a minimal reduction in the diameter will cause a significant effect on the resistance. This is particularly unfortunate for premature newborns that have tiny airway diameters that are significantly affected by the slightest reduction in airway diameter. Therefore the wall thickness of the tubing is already significantly reducing the effective inner diameter. These premature babies have the lowest amount of respiratory muscle strength. Thus it would be useful to provide a means for increasing the inner dimensions of the tube or to prevent constrictions of the tube of the type causing a lower internal diameter which adversely increases resistance. Achieving these objectives will decrease both the artificial and the patient-generated forces necessary for the life sustaining exchange of gases.
The internal diameter is further limited by the insertion of the endotracheal tube adapter within the endotracheal tube itself. The connecting portion of the adapter has a wall thickness which must insert into the endotracheal tube therefore causing a constriction of this male connector within the endotracheal tube. Some tubes come with the proximal portion of the endotracheal tube having a widened entry diameter. Yet the rigid adapter remains the same. In fact, the widened opening of the tube, with an adapter fitting snugly in, leads to difficulty inserting the connector into the tube when cut at a more distal location. The narrower endotracheal tubing must now accommodate a connector which is designed to fit into a larger opening. The tube must be expanded by the insertion of the connector.
Given that it is more difficult to put a relatively large male connector into an endotracheal tube requiring expansion of the tube, a larger force is required to accomplish this. This force is generally downward toward the patient that is intubated and supine. This downward force can cause dislodgement of the endotracheal tube from a desired, stable position and possibly down the bronchus of a single lung rather above the level of the corini, the bifurcation of the trachea. In fact an uncontrolled compensatory force upward against the downward insertion force may result in accidental extubation of the patient. In addition, the movement of the endotracheal tube downward could cause trauma, such as a rupture of a bronchus. Also, the delay caused by making a difficult connection can be detrimental to a patient who will have ventilation interrupted while this connection is attempted. This is particularly undesirable since a patient that is intubated in a resuscitation is by definition unstable and therefore, time delays are significant. In fact sometimes this connection is unattainable and a patient must have the endotracheal tube removed since without a connecting endotracheal tube adapter the tube is nonfunctional and dangerous. So in this scenario where a connection cannot be made between an endotracheal tube and an endotracheal tube adapter, the endotracheal tube must be removed so that ventilation can occur with a bag valve mask system. Thus it would be desirable to provide a means for decreasing the force necessary to attach a shortened endotracheal tube to an endotracheal tube adapter to prevent dislodgement of the endotracheal tube from a desirable position, and to provide a more stable means of attachment of the endotracheal tube and endotracheal adapter without increasing dead space.
The length and volume of the endotracheal tube and respiratory equipment determines the amount of physiologic dead space volume that the infant must overcome for the newborn to exchange gases with the outside environment. In the human, this dead space volume is enclosed within length of the trachea and larynx, with an exchange of gases normally occurring in the oropharynx, where gases with generated carbon dioxide are exchanged for ambient atmosphere including oxygen. Thus it would be of benefit to provide a means to reduce the amount of physiologic dead space by reducing the distance necessary between the respiratory circuitry of mechanical ventilation and the patient and by reducing the volume of gas contained within this length. Even minute changes in length and volume can have dramatic and clinically significant impact on the physical parameters of ventilation, and the ultimate outcome of these patients.
With respect to the problem of dripping in respiratory circuits, present endotracheal tube adapters typically have an upper cupped portion with a lower funneled portion forming the inner conduit for a male connector to an endotracheal tube. The funneled portion of the extension assists in the insertion of devices such as a stylet or a suction catheter through the full length of the adapter and into the endotracheal tube. As one can see from the configuration of this design, if there were any respiratory condensate dripping from above the endotracheal tube adapter, this condensate will be collected in the cupped upper portion and then funneled into the patient. If this condensation had been collecting for a significant period of time, it would be more prone to be contaminated with microorganisms and therefore their entrance into the patient could promote a pneumonia. Likewise, any secretion such a sputum that is expectorated through the endotracheal tube is likely to reenter due to the funneled nature of current endotracheal tubes, therefore thwarting the body's natural efforts to remove these products, which cause mechanical obstruction and promote deleterious infections. While it is common practice for nurses and therapists to routinely clear these secretions with intermittent suction to prevent a large accumulation of such products in the endotracheal tube or the lower respiratory tract, these procedures can only be intermittent and do not prevent the draining or reentrant actions described above. In between these suctioning procedures, the draining and reentrant actions increase the potential for deleterious effects including mechanical, hypoxia, infection, etc. Thus it would be of benefit to provide a means to prevent the draining or entrance of liquids from above the endotracheal tube adapter from entering the patient and to prevent the reentry of expelled liquids from reentering the patient.
It is also noted that the prior art does not describe efficient ways to provide feedback to the physician about the length of endotracheal tubing within the patient and beyond the view of the physician, such as visual feedback near the physician and tactile feedback near the physician. Nor does the prior art describe such feedback which is atraumatic to a patient, which is compatible with a reduced dead space connector system, which improves the efficiency of insertion or reinsertion of an endotracheal tube adaptor into an endotracheal tube, which improves the efficiency of shortening of an endotracheal tube to reduce dead space or that is compatible with the limitations of use in the small mouths and respiratory structures of premature newborns.
Another issue in the intubation process is the issue of monitoring. For example, the amount of pressure generated within the system is sometimes monitored during intubation. This is generally done by inserting a connecting component between the top of the endotracheal tube adapter and the ventilation device such as a resuscitation bag. Because this connecting piece is a separate item, it often is not used because it requires that a system be broken during ventilation. In addition, it's another piece of equipment that must be sterilized in between patient use or there is a risk of iatrogenically introducing infection. This can be cumbersome and costly. Also, in a field prehospital emergency or during transport, it may be difficult to carry numerous items; but this may be a time where tension may be highest background noise high and clinical experience the lowest. It would therefore be desirable to have a means for monitoring the respiratory system without the need to have an intermediate connector between the endotracheal tube adapter and the immediate passageway or sampling device to a detection device to increase clinical assessment.
With respect to visualization during procedures (e.g., intubations), in clinically assessing a patient or in performing a procedure, it is often necessary to illuminate the eyes or the mouth. There are many specialized devices to perform these functions. On a routine basis, this is accomplished with a standard pen light. These devices have the drawback of having a large diameter causing the body of the penlight to often obstruct the view, such as when one is looking in the small mouth of a baby. Another problem encountered in visualizing the mouth is that the tongue often obstructs the view. Commonly a spatula or tongue depressor is used in conjunction with an illuminator. Typically, one hand holds the tongue depressor and one holds the illuminator such as a penlight. In addition to visualization of the mouth, it is often necessary to perform sampling, such as when a swab is rubbed on the tonsils to obtain a culture. If one hand is used to accurately control the swab, then one must either sacrifice using a hand held illuminator or using a tongue depressor with the remaining hand. Another problem encountered in assessing patients with the available tools such as a penlight, is that when looking at a patient's eyes the circular field generated may these lights has varying intensities with the greatest intensity in the center. There is no sharp demarcation of lit and unlit regions; and it is therefore difficult to accurately assess the temporal point when illumination of a pupil elicits or fails to illicit a clinical response. It would be of benefit to provide a hand-held illuminator of the mouth that allows a user to have an unobstructed illuminated view of the posterior pharynx and, further, to provide a hand-held illuminator of the mouth that allows a user to use two hands to have an unobstructed illuminated view of the mouth and swab the tonsils. In addition, with respect to illuminators used for intubation, these items are often costly due to their limited use and the specific materials and designs used in their construction. It would therefore be desirable to have a illumination device that would have a design and construction of that would have multiple uses and be made of cheaper, preferably disposable materials. Having an inexpensive, hand-held portable illuminator that can be used in routine eye and throat examinations and can also be used if necessary in a resuscitation would be desirable. As an object and feature, preferably this device might also have indicia for resuscitation information such as medications, and preferably the device could be stored inconspicuously and handily in a shirt or coat pocket and could therefore be more readily available in any event of an emergency, rather than having to search for a more expensive, more specially designed laryngoscope with limited storage locations and availability.
With respect to irrigation problems, when a patient has a wound, it is desirable to irrigate the wound with a solution such as normal saline. Presumably the dilution effect of the irrigation will wash out bacteria and debris and prevent wound contamination, infection and scarring. The more fluid, the greater the degree of success in prevention. A higher pressure of irrigation could also help remove bacteria and debris and push out unwanted debris. Unfortunately, when using large volumes or high amounts of pressures, there is a high likelihood of contaminated fluid spreading to unwanted surfaces, including splashing onto a health care provider or drenching the patient. This is undesirable as the risk of spreading of disease is heightened and there are undesirable effects of getting a patient wet (for example, a trauma patient with multiple wounds might be hypothermic from a large amount of irrigation fluid evaporating on his body, or a child with a facial laceration might become hypothermic from the excess fluid wetting its clothing during the winter). The excess fluid will also soil laundry and require increased housekeeping services, using existing methods of irrigation. This is also an inconvenience for otherwise healthy patients. They may have to remove their clothing to prevent them from getting soaked. This may be uncomfortable for the patient in a busy emergency room; and the time necessary for the patient to disrobe would delay a doctor's or nurse's ability to treat such patient or other waiting patients more expeditiously. These disadvantages will decrease the incentive for an operator, such as a physician, to appropriately use optimal large volumes of irrigation fluid; and therefore the risk of wound complications will increase.
Some wound irrigation shields of the prior art have a circular base that prevents splashback of fluid onto the operator. However, this shield's round flat surface is non-conforming to most body surfaces that sustain lacerations, since the more commonly lacerated surfaces are on an edge or ridge or prominence rather than a flat surface (e.g., portions of arms or fingers, etc.). So use of such shields typically leaves open gaps where fluid can spray out and contaminate the nearby regions. Since the flat base surface of such devices can only be used in one plane when the base is placed with stability against the skin for support, a user is encouraged to use only the perpendicular positioned spraying orientation that the device provides, rather than angling the device in non-perpendicular orientations. Angling the spray would allow visualization from directly above—where the operator is most likely going to be looking from and where his viewpoint is more likely to be. Another problem with a generally perpendicular angle of an irrigation jet is that this configuration would tend to push wound bacteria or debris straight down and deeper into the wound. As an object and feature of my invention, angling the irrigation jet would give a horizontal vector to the forces on the bacteria and debris within the wound and this would tend to push the debris out of the wound rather than just farther into it. It would push the debris out of a wound by sometimes aiming the flow underneath the target and thus pushing it up by the upswelling of the irrigation fluid rather than jamming it farther in.
Nor does the prior art (in using such “perpendicular” splash shields) teach efficient methods of removal of large amounts of irrigating fluid. Typically, at present, workers must mop up the blood-tinged irrigation fluids with sheets and towels, with associated increased hospital wastes and costs and increased biohazard risks to hospital personnel, including risk of slipping on a wet floor, for example. A prior art device describing a wound irrigation shield with an irrigation removal system has a suction coaxially placed with the irrigation unit. That presents problems; such placement will distort the irrigation stream. In fact if the forces of the stream are small and the vacuum of the removal system is great, there may not be enough force for the stream to reach the wound. In addition, in the prior such systems, the removal outlet is high above the surface of the patient and therefore would be ineffective in suctioning fluid on a patient's body surface since it would have to have a strong vacuum to pull the irrigation fluid off the body up into the air and into the vacuum outlet. Thus it would be beneficial to provide a more efficient system and means for wound irrigation and irrigating-fluid removal.
Further objects and features of my invention are not taught in the prior art. There is no teaching of a wound splash shield device with an irrigation fluid jet that can be activated by suctioning or siphoning that provides an automatic irrigation stream that can deliver high volumes of irrigation; nor is there any teaching of a wound splash shield device with an irrigation fluid jet that can be activated by suctioning or siphoning that requires fluid to traverse a wound before reaching an outlet that provides an automatic irrigation stream that can deliver high volumes of irrigation fluid to cleanse the wound with minimal effort and also providing an effective removal means of this irrigation fluid. Nor is there teaching of this fluid, once activated, having a continual non-automatic stream powered by a continued suctioning or siphoning effect; nor is there teaching of such a device also having a flexible catheter attached to an inlet for suctioning or siphoning or such a device also being capable of accommodating a more active irrigation fluid delivery device such as a syringe to the same port or another port to enable one device to be capable of a variety of irrigation delivery techniques.
As most wounds are linear (or a combination of linear openings in the skin), the rounded lateral surfaces are generally wasted space that as shown above can actually be detrimental to optimal performance. There is no teaching in prior art of wound splash shields, as in a feature of my inventions, with a more elongated opening or base, which would be better suited for most wound surfaces to economize space and prevent the outpouring or spraying of debris and contaminated fluid. Nor is there teaching in prior art of wound splash shields with a contoured opening or base that would be better suited for most wound surfaces on body prominences to perform a better effective seal to improve the activation or operation of a suction- or siphon-controlled splash shield.
In addition, when an operator empties a syringe using the described prior art splash shield, the operator must actively detach the shield from the syringe. This active step is one more that will discourage a user that for example is in a busy emergency room, from using the optimal large volume of irrigation fluid.
Nor does the prior art give, as in a feature of my invention, a method of controllably causing a stable angled flow down a linear space. There is no teaching of a construction permitting and enhancing that an angled flow of a device can be rocked back and forth for providing an effective angular irrigation stream. Another disadvantage of a perpendicularly angled stream is that the force when in use of the plunger is pressing down directly on the skin. In general there are no lateral forces in a consistent direction that would ease the movement of the device from one region of a wound to another, particularly in a linear wound. Another drawback of the prior art is that there is no teaching of a vent or relief feature (as in my instant invention), for more safe and efficient suction of excess irrigation fluid; and there is no teaching of such a device with a suction powered removal system with a vent or relief feature that would prevent a full suction from occurring when the device's base formed a firm seal against a body surface. Such a suction force without a relief feature could pull the skin up into the device and cause damage and deformity to what might already be injured tissue.
Further, with respect to the design of improved wound irrigation shields, there are a number of standard type containers of sterile fluid (such as saline) in medicine. One of these is an “IV bag” which may contain sterile normal saline solution. The IV bags are compressible and therefore one could propel fluid through the outlet and onto a wound. One prior-art method of doing this shows a connector with an inlet end that inserts into an IV bag and an outlet end that has a “syringe tip”. Such a device has already been available in the form of a connector that has a sterile needle end with variable dimensions and an outlet end with a “syringe tip”. These devices suffer the lack (provided as a feature of my present invention) of a barrier to restrain splashed fluid. Such barrier are more and more generally used in medicine due to the risk of blood-borne disease such as HIV. And using connectors between such devices has numerous limitations. Assembling the devices together by the available friction fits requires time. Multiple separate devices might need to be unloaded out of sterile containers, resulting in increased time for the procedure, increased waste of packaging, increased cost of packaging and increased risk of the parts or the users breaking sterile protocols. In addition, vigilance during the procedure is required to assure that the devices do not disconnect. If such a disconnect occurred during a procedure unexpectedly, this would lead to a dangerous situation where a clinician might be exposed to a patient's bodily fluids and or where fluid might drench a patient or hospital room. This problem of disconnecting may be particularly a problem with the use of a compressible IV bag, as the act of manual compression requires a significant amount of force and might leave a user's hands shaky and unstable causing the assembled unit to be moved around quite a bit, possibly separating the unit apart.
Another limitation of the prior art is that the devices that do have splash shields have only one aperture for injection and therefore allow for only one size of jet stream. It is common to have many user preferences in wound irrigation. Some might prefer a quicker, lower-pressure higher-volume large-aperture injection and others might prefer a slower, higher-pressure lower-volume narrower-aperture injection. Prior art devices only allow for one type of injection stream through a single aperture. Or such devices can accept different IV catheter hub and tubing assemblies with different diameters to vary the pressure and flow; but this method requires additional assembly and the use of additional costly sterile packaging with disadvantages such as those described above. Others in the prior art use a single injection inlet with a complex mechanically powered water injection unit with a variable motor unit. This unit is costly and cumbersome and unlikely to be disposable. Its bulk makes it cumbersome for maneuvering on different parts of a patient's body. There are now no manually operated wound irrigation shields and injectors that have an inlet mechanism that allows for simple variation of injection flow (as in my present invention) to easily accommodate for user preferences. Such a device would gain broader acceptance and use; and it would reduce the stocking of multiple models or parts and would eliminate the need for assembly of connectors. Nor do any of these (as in my present invention for eliminating the problems set forth in this paragraph) have such a mechanism using IV spikes as connector inlets. Nor do any of these have a mechanism using an IV spike as a connector and having grooves or protrusions for stabilizing the interface between the squeeze bag or tube such as an IV bag and the shielding device. Nor do they have any means for improving the gripping means, or providing a flat surface for pivoting the injection stream. Nor do any of these have such a mechanism using a single part with an irrigation shield. Nor do any of these mechanisms have connectors that fit inside the already standardized fluid container outlets. Current wound irrigation shields fit over the fluid container outlets of the device and the increased diameter increases the visual obstruction caused by the connection. Even minor increases in diameter can be of significance for wound irrigation shields that are small relative to the size of the fluid container which may already be causing a visual obstruction.
With respect to providing more efficient syringes, it is noted that syringes are commonly used in medicine to deliver medication or medicants or fluids for medical therapies or medical procedures. They consist of a cylindrical body with a tip and plunger that expands or contracts an inner reservoir. Commonly there are markings on the side to indicate volumes associated with the size of the reservoir and the syringe has a tip that assists in the delivery of contents and assists in making connections. As these are manually operated, the devices are to a great extent limited by the dimensions of the hand. Syringes are often placed in containers and bottles with round openings. These openings likewise restrict the function and therefore the size of the barrel of the syringe being inserted. As most medical containers have screw on caps or lids for achieving a good seal or for safety, the bottles must be opened with a twisting of the hand and they are again limited in size by the limitations of the gripping size of a hand. The syringe barrels must therefore be smaller than these cap dimensions to fit within a container opening with such a cap. While one could get around this problem by pouring the containers into an open basin or bath, this is not always practical. It adds more equipment. The transfer or open storage might risk contamination of a sterile content and the contents might be sensitive to the openness if they are more prone to light sensitivity or oxidation for example. Therefore, container storage with a cap or lid, particularly a round one, does have significant advantages. Unfortunately, in a situation where the container (such as a bottle) has a narrow opening that may be limited by the volume of the bottle, one must also use a more narrow syringe. As the diameter of the barrel of a syringe narrows, the total volume that may be contained within its reservoir per unit length is decreased.
Having a compressible reservoir delivery system, including a syringe, with a relatively low volume to unit length ratio has certain advantages in some circumstances. This is a common design for use when fine control over the delivery of a substance may be required, as in a chemistry or pharmaceutical lab for example. Another example in working with human medicine is working with premature newborns in an intensive care unit. Their small size requires much smaller volumes. Delivery systems with fine control of delivery are necessary as other options have drawbacks. For example, if one wanted fine control over delivery of 5 cc. of a medication, one could dilute this medicine so there would be a larger volume and hence a longer length in the delivery system of a desired medication being delivered and therefore finer control.
Unfortunately, this additional volume may contribute to fluid overload and potentially congestive heart failure in some fluid restricted premature newborns. The prior art often has small narrow 1 cc. syringes less than a single handspan in length. If one required fine control over the instillation of 5 cc. over a short or extended time period into the IV system of a premature newborn for example, one would have to remove the fine 1 cc. syringe five times. This would have a risk of contamination of this system with bacteria or air bubbles, for example, being at least five times greater. The prior art does not describe a single hand held and operated compressible reservoir with a plunger such as a syringe with a narrow barrel for fine control over the fine delivery of the reservoir contents that can have a length that can easily be operated with control over the syringe for instillation or removal instantaneously and using a larger length and therefore a larger volume, especially a length greater than a single hand span.
Another disadvantage of prior art comes in the area of wound irrigation. It is desirable to use a large volume of fluid and fluid under pressure to irrigate a wound to remove bacteria and debris and reduce wound complications. Current art of syringes requires that one use a syringe with a limited volume multiple times to draw up irrigation fluid and then expel it. If a larger volume syringe is desired to reduce the time consuming and cumbersome steps of drawing up fluid and expelling it, the syringe diameter is limited by the size of a irrigation container opening. As previously described, resealable irrigation containers, such as bottles are preferable to open basins or baths. It is also desirable to have a single hand operated syringe for reasons also described above, including the fact that a second hand may be stabilizing other equipment such as a splash shield. Prior art limits the dimension of a single hand operated syringe used in an irrigation procedure with a resealable irrigation fluid container to be of a dimension with a barrel width narrower than the irrigation fluid container and a length less than a single hand span. Current art does not teach having a larger volume syringe for this purpose, or more specifically having a longer single hand operated syringe with a simple plunger delivery of the reservoir contents.
Another disadvantage of the prior art in the delivery of contents is the delivery of contents that require a higher pressure to deliver. Examples are fluids such as normal saline that is pushed through a small aperture under high pressure for improved irrigation results or such as high viscosity fluids, including a slurry of activated charcoal to be delivered through a tube to a patient with an overdose. As syringes are hand operated, when a hand, including a fully extended thumb and gripping fingers are extended and intended to contract to operate the syringe, it is in a less stable position than in a less than extended or contracted position. It is therefore desirable to have a syringe that reduces the instability of a hand operated syringe delivering contents under high pressure when the plunger is an extended, including fully extended position. Unfortunately, the prior art does not address this need adequately, and syringes that require high pressure often require two hands for operation to maintain stability or possibly require the device to be placed against the body for example. One attempt at addressing this concern is to have improved gripping means on the barrel of the syringe and at the end of the syringe plunger. Unfortunately, when the syringe is in a fully extended position, the system is still relatively unstable, especially when high pressure is necessary to hand operate the device. Additionally, if the syringe were of a length greater than one hand length, the syringe could not be operated by one hand and would therefore require more manipulations to operate.
Additionally with regard to gloves, they are sometimes worn to prevent the contact not only with infectious agents, but also to prevent contact with toxic or dangerous compounds. This is true not only in medicine, but in non-medical settings as well. One such “toxic” compound is a tissue adhesive by the trade name Dermabond™. This is the biocompatible or equivalent of the product, cyanoacrylate, commonly known as “SuperGlue”. This substance can be dangerous or toxic to humans in certain situations such as when it causes the unwanted adherence of two skin surfaces. Unfortunately when bringing together two items with these substances, one often inadvertently bonds two other surfaces, such as the surface of the skin. Specifically, in the procedure of adhering two approximated wound edges with Dermabond, the medical personnel often get the Dermabond on the fingers undesirably when applying to wound, as the wound must be approximated with the fingers and the glue is often non-viscous. Bonding of the fingers causes delays in trying to remove it or causes an unsightly and undesirable film on the finger surfaces for example. To prevent this, personnel often wear gloves. Gloves are also necessary as medical personnel must observe universal precautions with even minor wounds. Unfortunately, the commonly used latex gloves often bond to themselves preventing manipulation. They also bond to the skin of the patient. Not only is this inconvenient to detach the medical personnel from the patient, but the distraction force required to remove the glove from the skin surface can cause a dehiscence of the recently approximated wound.
One solution has been the development of wound forceps by Bionix Corp. These bring the skin surfaces together without direct contact of the user or their gloves with skin surface. Unfortunately, these devices are bulky relative to most wounds, they restrict the user to only certain dimensions of wound approximation achieved by the forceps dimensions, they are specifically designed for flat surfaces and do not work well on the rounded, sharper contours and body prominences that are more wound prone and more commonly lacerated. They are not designed for wound closure by distraction of skin surfaces, such as the linear ends of a wound, which often provides better approximation than medially directed pressure.